NA 03.045.018Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982293220), received between Jun 27, 2023 and Jun 27, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 27, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2023, WHILE ATTEMPTING TO DRILL FOR PROXIMAL LOCKING SCREWS FOR A TIBIAL NAIL ADVANCED (TNA) NAIL IN THE S1 HOLE, THE DRILL BIT HIT THE NAIL. THE NAIL WAS NOT ALIGNED PROPERLY. THE SURGEON CHECKED THE NAIL FOR TIGHTNESS AND WAS ABLE TO GET A TURN TO TIGHTEN THE NAIL. SURGEON DETERMINED THAT THE NAIL LIKELY MISALIGNED BECAUSE IT BECAME LOOSE FROM THE HANDLE. THEY WERE ULTIMATELY ABLE TO GET THE DRILL BIT AND SCREW THROUGH THE NAIL. ADDITIONALLY THE T-HANDLE CHUCK SEEMED TO TURN FREELY WHEN IT SHOULD HAVE BEEN TIGHT. THE DRILL TIPPED K-WIRE ALSO WAS DIFFICULT TO REMOVE FROM THE INSIDE OF THE OPENING DRILL BIT. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH A FIFTEEN MINUTE DELAY. THERE WAS NO PATIENT CONSEQUENCE; PATIENT WAS STABLE. THIS REPORT IS FOR A GUIDE WIRE- W/ DRILL TIP Ø 3.2MM/ 400MM. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17210433 ↗